Supra-Annular vs. Annular ValvEs for Small Annuli
Withdrawn before enrolling · Not applicable
Conditions studied: Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
In brief
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
Key facts
- Study ID
- NCT04372381
- Run by
- University of Arizona
- People needed
- 0
- Starts
- 2020-05-12
- Expected to finish
- 2025-04-30
- Last updated by the study team
- 2026-07-24
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Symptomatic subjects with severe native aortic valve stenosis
- aortic valve annulus mean diameter ≤23 mm
- Patient meet commercial indication for transcatheter aortic valve replacement (TAVR)
- Institutional heart team determines that TAVR is appropriate
- Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra
You may not qualify if…
- Subject unable or unwilling to provide informed consent
- Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure)
- Renal function precluding the administration of iodinated contrast (eGFR < 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media
- Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures
- Patients at high risk for coronary obstruction
- Patients with low-flow low gradient aortic valve stenosis
- patients at high risk for annular rupture with implantation of a balloon expandable valve
Where it is running
- Banner - University Medical Center, Phoenix campus — Phoenix, Arizona, United States
- Tucson Medical Center — Tucson, Arizona, United States
- Delray Medical Center — Delray Beach, Florida, United States
Full record on ClinicalTrials.gov
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